ambrisentan

Product NDC
50090-7671
11-digit product format
500907671
Labeler code
50090
Product ID
50090-7671_364758a6-9e0a-4ef9-8019-4bc320bdc9b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ambrisentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216531
Marketing category
ANDA
Marketing start
2022-07-21
Substance
AMBRISENTAN
Active strength
5 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ambrisentan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBRISENTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHW6NV07QEC
Rxcui722122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7671-0ambrisentan30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722122ambrisentan 5 MG Oral TabletPSNfda3e8b5-267b-4690-85c2-78626986245c1
722122ambrisentan 5 MG Oral TabletSCDfda3e8b5-267b-4690-85c2-78626986245c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7671-05009076710030 TABLET, FILM COATED in 1 BOTTLE (50090-7671-0) 2025-10-07NoNoCurrent